Lung Cancer Clinical Trial

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

Summary

The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD[s]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).

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Full Description

Lung cancer is one of the most frequently diagnosed cancers and the leading cause of cancer related deaths worldwide. It is a heterogenous disease and is broadly classified as non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study will combine the 2 mesenchymal-epithelial transition (MET) inhibitors, amivantamab and capmatinib, which have different mechanisms of MET inhibition and, as monotherapies, have demonstrated clinical activity in MET driven NSCLC. Amivantamab is a bispecific antibody that targets both the epidermal growth factor receptor (EGFR) and MET extracellular ligand binding domains and inhibits ligand driven signaling. Capmatinib is a selective, oral MET tyrosine kinase inhibitor (TKI) that inhibits the MET downstream signaling pathway and thereby inhibits tumor growth and progression. The primary hypothesis of the study is that amivantamab and capmatinib can be safely administered as a combination therapy, with a tolerable safety profile (Phase 1), and the combination of amivantamab and capmatinib will demonstrate clinically significant anti-tumor activity for participants with NSCLC harboring MET exon 14 skipping mutations or MET amplification (Phase 2). The study will include a screening period, a treatment period , and a post-treatment follow-up period. The overall duration of the study will be up to 2 years 1 month.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)
May have: definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to [<=]10 milligrams (mg) prednisone or equivalent) for at least 2 weeks prior to start of study treatment
May have a prior malignancy (other than the disease under study) the natural history or treatment of which is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
A female participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion Criteria:

Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets
Participant has symptomatic central nervous system (CNS) metastases which are neurologically unstable or have required increasing doses of steroids >10 mg prednisone or equivalent within the 2 weeks prior to study entry to manage CNS symptoms
Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy (example, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the administration of the first study treatment

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

161

Study ID:

NCT05488314

Recruitment Status:

Not yet recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 87 Locations for this study

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University of California, Irvine
Orange California, 92868, United States
The Oncology Institute of Hope and Innovation
Whittier California, 90603, United States
University of Chicago
Chicago Illinois, 60637, United States
Montefiore Einstein Center for Cancer Care
Bronx New York, 10467, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States
PERSONAL - Oncologia de Precisão e Personalizada
Belo Horizonte , 30130, Brazil
CIONC - Centro Integrado de Oncologia de Curitiba
Curitiba , 80810, Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas , 96020, Brazil
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre , 90610, Brazil
Oncoclínicas
Rio de Janeiro , 22250, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Rio de Janeiro , 22281, Brazil
Núcleo de Oncologia da Bahia
Salvador , 40170, Brazil
Fundação Antônio Prudente - A.C. Camargo Cancer Center
Sao Paulo , 01509, Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo , 01308, Brazil
The Ottawa Hospital Research Institute
Ottawa Ontario, K1Y 4, Canada
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto Ontario, M5G 1, Canada
Beijing Cancer Hospital
Beijing , 10014, China
Sichuan Cancer Hospital
Chengdu , 61004, China
West China Hospital, Sichuan University
Chengdu , 61004, China
Chongqing University Cancer Hospital
Chongqing , 40003, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou , 51006, China
The First Affiliated Hospital, Zhejiang University College of Medicine
Hangzhou , 31000, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou , 31000, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou , 31001, China
Harbin medical university cancer hospital
Harbin , 15008, China
Huizhou Municipal Central Hospital
Huizhou , 51600, China
Fudan University Shanghai Cancer Center
Shanghai , 20003, China
Shanghai Pulmonary Hospital
Shanghai , 20043, China
Shengjing Hospital of China Medical University
Shenyang , 11005, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'An , 71006, China
Yantai Yuhuangding Hospital
Yantai , 26400, China
Henan Cancer Hospital
Zhengzhou , 45000, China
Institute Coeur Poumon
Lille , 59000, France
Centre Leon Bérard
Lyon Cedex 8 , 69008, France
CHU de la Timone
Marseille , 13005, France
Institut Curie
PARIS Cedex 5 , 75248, France
Institut de cancerologie de l'ouest
Saint-Herblain Cedex , 44805, France
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg cedex , 67091, France
Charite Universitaetsmedizin Berlin
Berlin , 12203, Germany
Helios Klinikum Emil von Behring GmbH
Berlin , 14165, Germany
Klinikum Chemnitz gGmbH
Chemnitz , 09116, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden , 01307, Germany
Universitaetsklinikum Essen
Essen , 45147, Germany
Universitaetsklinikum Koeln
Koeln , 50937, Germany
Universitaetsklinikum Muenster
Muenster , 48149, Germany
Munchen Klinik GmbH Klinik Bogenhausen
München , 81925, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS
Napoli , 80131, Italy
Istituto Oncologico Veneto - IRCCS
Padova , 35128, Italy
Ospedale S. Maria Delle Croci
Ravenna , 48121, Italy
Istituto Nazionale Tumori Regina Elena
Rome , 00128, Italy
National Hospital Organization Nagoya Medical Center
Nagoya-shi , 460-0, Japan
Shizuoka Cancer Center
Sunto-gun , 411-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of
National Cancer Center
Goyang-Si , 10408, Korea, Republic of
Gachon University Gil Hospital
Incheon , 21565, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp. z o.o.
Lublin , 20-60, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Hosp. Univ. A Coruña
A Coruña , 15006, Spain
Hosp. Gral. Univ. de Alicante
Alicante , 03010, Spain
Hosp. Del Mar
Barcelona , 08003, Spain
Hosp. Univ. Quiron Dexeus
Barcelona , 08028, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Clinic I Provincial de Barcelona
Barcelona , 08036, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. La Paz
Madrid , 28046, Spain
Hosp. Virgen Macarena
Sevilla , 41009, Spain
Hosp. Clinico Univ. de Valencia
Valencia , 46010, Spain
Memorial Ankara Hastanesi
Ankara , 06520, Turkey
Gazi University Hospital
Ankara , 06560, Turkey
Ankara Bilkent City Hospital
Ankara , 06590, Turkey
Liv Hospital Ankara
Ankara , 06680, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul , 34722, Turkey
UCL Cancer Institute
London , NW1 2, United Kingdom
Imperial College London and Imperial College Healthcare NHS Trust
London , W2 1N, United Kingdom
Freeman Hospital
Newcastle , NE7 7, United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

161

Study ID:

NCT05488314

Recruitment Status:

Not yet recruiting

Sponsor:


Janssen Research & Development, LLC

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